Indications for: OCREVUS
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Primary progressive MS.
Screen for HBV infection and test for serum immunoglobulins prior to initiation. Premedicate with corticosteroid and antihistamine prior to each infusion; may consider antipyretic. Initially 300mg by IV infusion, followed by a second 300mg infusion 2 weeks later, then subsequently as one 600mg infusion every 6 months. For infusion rates, duration, and dose modifications: see full labeling.
Active HBV infection. History of life-threatening infusion reaction to ocrelizumab.
Monitor for infusion reactions during and at least 1hr after therapy completion; permanently discontinue if life-threatening infusion reactions occur; treat appropriately. Delay Ocrevus in those with active infection until resolved. Discontinue if serious herpes infection occur; withhold until resolved. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate; discontinue if PML is confirmed. HBV reactivation: screen all patients for HBV; if positive HBsAg/anti-HB results, do not administer Ocrevus. Monitor serum immunoglobulin levels during and after therapy, until B-cell repletion, and esp. during recurrent serious infections. Consider discontinuing therapy in those with opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires IV immunoglobulins. Increased risk of malignancy (including breast cancer). Monitor for immune-mediated colitis during therapy; evaluate promptly if signs/symptoms occur. Complete all immunizations according to guidelines at least 4 weeks (for live or live-attenuated vaccines) or at least 2 weeks (for non-live vaccines) prior to initiation. Infants born to mothers treated during pregnancy: do not administer live or live-attenuated vaccines before confirming B-cell recovery; non-live vaccines may be given prior to recovery, but should consider assessment of vaccine immune response. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Pregnancy. Nursing mothers.
CD20-directed cytolytic monoclonal antibody.
Concomitant live or live-attenuated vaccines: not recommended during treatment and until B-cell repletion. May interfere with the effectiveness of non-live vaccines. Additive immunosuppressive effects with other immunosuppressants; consider the duration and effects when switching from immunomodulators (eg, corticosteroids, daclizumab, fingolimod, natalizumab, teriflunomide, mitoxantrone).
Upper/lower respiratory tract infections, infusion reactions (eg, pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, others), skin infections; herpes virus-associated infections.
Constant clearance was estimated at 0.17 L/day, and initial time-dependent clearance at 0.05 L/day, which declined with a half-life of 33 weeks. The terminal elimination half-life was 26 days.
Generic Drug Availability:
Single-dose vial (10mL)—1